Darolutamide is an oral second-generation androgen receptor antagonist approved by the US FDA in 2019. For the treatment of non-metastatic castration-resistant and metastatic castration-sensitive prostate cancer, clinical guidelines recommend androgen receptor antagonists, such as darolutamide, in combination with androgen-deprivation therapy as the standard of care. Unlike other second-generation androgen receptor antagonists, darolutamide has a distinct structure, which may offer advantages in tolerability and efficacy. With approval for both of these advanced prostate cancer types, darolutamide stands out as a key therapeutic option. Darolutamide primary patent has been granted in many LMICs and is expected to expire in May 2030. The patent term has been extended in few LMICs until 2035. Secondary patents have not been identified in LMICs.

acronyms & abbreviations list